Validating Non-invasive Measurements of Central Blood Pre... | NCT01538290

Studies
Validating Non-invasive Measurements of Central Blood Pressure in Type 2 Diabetic Patients

NCT01538290

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Jun 12, 2012Estimated

Enrollment

34Actual

Phase

Not provided

Conditions

Diabetes Mellitus, Type 2
Blood Pressure

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Mar 2012Actual

Completion Date

Mar 2012Actual

First Submitted Date

Feb 20, 2012

First Submission Date that Met QC Criteria

Feb 23, 2012

First Posted Date

Feb 24, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2012

Last Update Posted Date

Jun 12, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigators want to validate two non-invasive devices for the determination of central blood pressure, i.e. blood pressure in the aorta (artery leaving the heart).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

34Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diabetes Mellitus, Type 2
Age above 18 years

Exclusion Criteria:

Atrial fibrillation or other cardiac arrhythmia
known stenosis of aorta or arteria subclavia/brachialis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patient with type 2 diabetes mellitus referred to elective coronary angiography.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hans Erik Bøtker, MD,Professor	Aarhus University Hospital, Skejby, Department of Cardiology	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus University Hospital, Skejby, Department of Cardiology		Aarhus		8000	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24304654	Derived	Laugesen E, Rossen NB, Peters CD, Maeng M, Ebbehoj E, Knudsen ST, Hansen KW, Botker HE, Poulsen PL. Assessment of central blood pressure in patients with type 2 diabetes: a comparison between SphygmoCor and invasively measured values. Am J Hypertens. 2014 Feb;27(2):169-76. doi: 10.1093/ajh/hpt195. Epub 2013 Dec 4.
23996499	Derived

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases